Warnings and Precautions

There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

Warnings

There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.

Precautions

PRECAUTIONS Neurologic (5.1)Gastrointestinal There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures. The seizure cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia). The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia. Monitor baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients. (5.2) Renal Insufficiency Use with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex and patients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible. (5.3) Allergic Reaction Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes (sodium, potassium, calcium, BUN and creatinine). (5.4)Allergic Reaction Hives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction.

Drug Interactions

DRUG INTERACTIONS
Oral medication administered within one hour of the start of administrationof HalfLytely solution may be flushed from the GI tract and the medicationmay not be absorbed. (7)
Do not take the Bisacodyl delayed release tablets within one hour of takingan antacid. (7)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labelingRevised: 10/2007
FULL PRESCRIBING INFORMATION: CONTENTS *
1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.
1 Neurologic
2 Gastrointestina
3 Renal Insufficiency

4 Allergic Reaction
5 ADVERSE REACTIONS

Clinical Studies

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials, abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions ( 3%) after the administration of HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping. The data in reflects exposure in 222 patients to HalfLytely and 10 mg Bisacodyl tablets vs. 223 patients exposed to HalfLytely and 20 mg Bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age, 46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of the comparator group were similar.

USE IN SPECIFIC POPULATIONS

8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness in pediatric patients has not been established. 8.5 Geriatric Use Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

PREGNANCY

Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in pediatric patients has not been established

GERIATRIC USE

Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.

MECHANISM OF ACTION

PHARMACODYNAMICS

Bisacodyl, a stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite [bis-(p-hydroxyphenyl) pyridyl-2 methane; (BHPM)] that acts directly on the colonic mucosa to produce colonic peristalsis.

PHARMACOKINETICS

The osmotic activity of HalfLytely solution results in no net absorption or excretion of ions or water.

Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of HalfLytely and Bisacodyl Tablets Bowel Prep Kit. Studies to evaluate its potential for impairment of fertility or its mutagenic potential have not been performed.

STORAGE AND HANDLING

STORAGE AND HANDLING17
PATIENT COUNSELING INFORMATION17.4 FDA-Approved Patient Labeling * Sections or subsections omitted from the full prescribing information are not listed page 2 of 6 FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGEHalfLytely and Bisacodyl Tablets Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
2 DOSAGE AND ADMINISTRATIONThe recommended HalfLytely and Bisacodyl Tablets Bowel Prep Kit oral dosage regimen for adults on the day prior to colonoscopy isas follows: Take two 5 mg Bisacodyl delayed release tablets with water. Do NOT chew or crush the tablets.Add flavor pack of choice (if applicable) to the 2 liter container. No additional ingredients (other than flavor packs provided) shouldbe added to the solution.Prepare the HalfLytely solution by filling the container to the 2 liter mark with water.
Cap the container. Shake to dissolve thepowder.Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10minutes. Drink all of the solution.3 DOSAGE FORMS AND STRENGTHS Two pink, round, enteric coated 5 mg Bisacodyl delayed release tablets, stamped 223BRA224 One 2 liter HalfLytely bottle with powder for reconstitution4 CONTRAINDICATIONSThe HalfLytely and Bisacodyl Tablets Bowel Prep Kit is contraindicated in the following conditions: Known allergies to polyethylene glycol or other components of the kit Gastrointestinal (GI) obstruction Bowel perforation Toxic colitis Toxic megacolon5 WARNINGS AND PRECAUTIONS5.
1 NeurologicThere have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparationproducts in patients with no prior history of seizures.
The seizure cases were associated with severe vomiting, excessive beverageconsumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia).
The neurologic abnormalities resolved withcorrection of fluid and electrolyte abnormalities. Therefore, HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used withcaution in patients using concomitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients withknown or suspected hyponatremia. Monitor baseline and post-colonoscopy.

LABORATORY TESTS

laboratory tests (sodium, potassium, calcium, creatinine,and BUN) in these patients.
5.2 GastrointestinalUse with caution in patient with severe ulcerative colitis, ileus or gastric retention. Observe patients with impaired gag reflex andpatients prone to regurgitation or aspiration during administration of HalfLytely solution. If GI obstruction or perforation is suspected,appropriate studies should be performed to rule out these conditions before administration. There have been reports of ischemic colitisin patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit. If patients develop severe abdominal pain or rectalbleeding, patients should be evaluated as soon as possible.
5.3 Renal InsufficiencyPatients with impaired water handling who experience severe vomiting should be closely monitored including measurement ofelectrolytes (sodium, potassium, calcium, BUN and creatinine).
5.4 Allergic ReactionHives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction. page 3 of 6 6 ADVERSE REACTIONS
6.1 Clinical Studies ExperienceBecause clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of adrug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.In a clinical study of HalfLytely and (10 mg vs. 20 mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials,abdominal pain/cramping, nausea, vomiting and headache were the most common adverse reactions (< 3%) after the administrationof HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit. Less than 1% of patients exposed to HalfLytely and 10 mgBisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping.The data in Table 1 reflects exposure in 222 patients to HalfLytely and 10 mg Bisacodyl tablets vs. 223 patients exposed to HalfLytelyand 20 mg Bisacodyl tablets. The HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age,46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy. The demographics of thecomparator group were similar.Table
1: Adverse Reactions Observed in at Least 1% of Patients HalfLytely and 10 mgBisacodyl TabletsBowel Prep Kit (N=222) HalfLytely and 20 mgBisacodyl TabletsBowel Prep Kit (N=223) Abdominal pain/cramping 1% 2% Nausea 1% 2% Vomiting 1% 2% Headache 2% 1% Table 2 displays patient diary ratings of their symptoms associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kits (10 mgBisacodyl vs. 20 mg Bisacodyl tablets) in the controlled trial.Table 2: Percentage of Patients Reporting in their Diaries 223bothersome224 to 223severely distressing224 Symptoms in Controlled ClinicalHalfLytely and Bisacodyl Tablets Bowel Prep Kit Trial1 Half Lytely and 10 mgBisacodyl TabletsBowel Prep Kit (N=222) HalfLytely and 20 mgBisacodyl TabletsBowel Prep Kit (N=223) Nausea 13% 21% Abdominal cramping 7% 14% Abdominal fullness 11% 13% Vomiting 5% 8% Overall Discomfort 14% 20% 1 Patients were specifically asked about the occurrence of the following symptoms: nausea, abdominal cramping, fullness, vomiting,and overall discomfort.
6.2 Postmarketing ExperienceThe following adverse reactions have been identified during postapproval use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit.Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposure.Allergic Reactions: Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based productswhich may represent allergic reactions.Gastrointestinal:There are isolated reports of serious post-marketing events following the administration of PEG-based products in patients over60 years of age. These adverse reactions include upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole,and acute pulmonary edema after vomiting and aspirating the PEG-based solution. In addition, during administration of 4 liters ofPEG-3350 colon cleansing preparation the following serious adverse reactions were seen: two deaths in end stage renal failure patientswho developed diarrhea, vomiting and dysnatremia.Ischemic colitis has been reported with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit for colon preparation prior tocolonoscopy. However, a causal relationship between these ischemic colitis cases and the use of HalfLytely and Bisacodyl TabletsBowel Prep Kit has not been established. page 4 of 6 Neurologic: There have been reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) PEG-basedcolon preparation products in patients with no prior history of seizures. Cases of dizziness and syncope have been reported [seeWarnings and Precautions (5.1)]
.7 DRUG INTERACTIONS Oral medication administered within one hour of the start of administration of HalfLytely solution may be flushed from the GI tractand the medication may not be absorbed.Do not take the Bisacodyl delayed release tablets within one hour of taking an antacid.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether HalfLytely and BisacodylTablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. HalfLytelyand Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed.
8.3 Nursing MothersIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should beexercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.
8.4 Pediatric UseSafety and effectiveness in pediatric patients has not been established.
8.5 Geriatric UseOf the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 yearsof age or older, while 18 (8%) were 75 years of age or older. No overall differences in safety or effectiveness were observed betweengeriatric patients and younger patients, and other reported clinical experience has not identified differences in responses betweengeriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.11 DESCRIPTIONEach HalfLytely and Bisacodyl Tablets Bowel Prep Kit [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonateand potassium chloride for oral solution and Bisacodyl delayed release tablets] consists of one 2 liter bottle of HalfLytely (PEG-3350,sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg Bisacodyl,delayed release tablets.Bisacodyl delayed release tablets: Each pink, round, enteric coated Bisacodyl delayed release tablet (stamped 223BRA224) contains5 mg of Bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40.

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